Principal Quality Management Systems Specialist, Sterilization

What you will do

• Ensure compliance and maintenance of the Quality Management System (QMS) at the Stryker Sterilization facility in Tijuana, Mexico.

• Act as a subject matter expert on FDA Quality System Regulation, MDSAP regulations, ISO 11135, and ISO 13485 standards.

• Support internal and external quality system audits, ensuring compliance.

• Lead investigations, manage non-conformances (NC), and perform CAPA review and approval tasks.

• Develop and maintain Power BI dashboards related to the QMS, in collaboration with Corporate RAQAC analytics.

• Train new QMS specialists on Stryker’s procedures and sterilization quality management systems.

• Plan and execute internal audits based on the processes of the sterilization organization.

• Coordinate and provide applicable compliance training.

• Interpret and apply regulations such as FDA, ISO, MDSAP, EU MDR, and Stryker policies.

• Conduct trend analysis on key performance indicators and organize Management Reviews.

What you need

• BS in a science, engineering, or related discipline. Master’s degree or equivalent preferred.
• 7+ years of similar experience in a high regulated industry.
• Exerience with the following regulations/standards preferred: 21 CFR Part 820, MDSAP, ISO standards (e.g., ISO 13485:2016, ISO 14971:2019) and ISO 11135 – Ethylene Oxide Sterilization.
• Solid knowledge of manufacturing processes, statistical techniques, environmental controls and basic Regulatory requirements for medical devices.
• Strong knowledge of quality management system processes (NC/CAPA, Complaints Handling, Management Review, Quality Planning, etc.).
• Bilingual (English & Spanish).
• Utilize proper software to maintain project records, MS Office, SharePoint, Visio and Power BI.